Recurrent grade II and grade III gliomas MedDRA version: 19.0 Level: LLT Classification code 10027744 Term: Mixed astrocytoma-oligodendroglioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10060971 Term: Astrocytoma malignant System
Conditions
Sponsors
European Organisation for Research and Treatment of Cancer (EORTC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven grade II or grade III astrocytoma, oligodendroglioma or oligoastrocytoma. - Demonstrated absence of 1p/19q co-deletion. - Availability of tumor material for central review processes and translational research projects - First recurrence after initial treatment with either radiotherapy and/or chemotherapy. - Enhancing recurrence on MRI scan. - Absence of any cardiovascular disorder. - Absence of any thrombotic or hemorrhagic issue. - Absence of known hypersensitivity. - No underlying or previous conditions that could interfere with treatment. - Normal hematological functions. - Normal liver function. - Normal renal function. - Age = 18 years. - WHO Performance status 0 - 2. - Women of childbearing potential (WOCBP) must be using an adequate method of contraception - Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Informed consent should also be given for biological material to be stored and used for future research on brain tumors. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
Exclusion criteria: - More than one line of chemotherapy. - Radiotherapy within the three months prior to the diagnosis of progression. - Radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven. - Prior treatment with Bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors - Invasive procedures within 4 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to compare the activity of both the combination Temozolomide (TMZ) plus bevacizumab and TMZ alone in recurrent grade II or grade III glioma patients without 1p/19q co-deletion. ; Secondary Objective: Secondary objectives: Safety, patient-oriented assessment of clinical benefit. Exploratory objectives: qualification or discovery of prognostic and/or predictive biomarkers of activity or efficacy. Discordances between RANO and Macdonald's criteria. ;Primary end point(s): The primary endpoint will be probability of survival at 1 year (i.e. patients alive at 12 months, OS12).;Timepoint(s) of evaluation of this end point: After 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -response (distribution, objective response rate, duration of response, according to RANO criteria) -progression free survival distribution according to RANO criteria (PFS : distribution, PFS 6 and PFS 12) - Overall survival : distribution and OS 24 complete safety profile, -patient-oriented criteria: clinical/neurological deterioration free survival, steroid use, quality of life (by patients and caregivers/relatives) and development of cognitive deterioration ; Timepoint(s) of evaluation of this end point: After 6, 12 and 24 months. Clinical/neurological deterioration free survival, steroid use, quality of life (by patients and caregivers/relatives) and development of cognitive deterioration until progression disease. | — |
Countries
Austria, Belgium, Germany, Italy, Netherlands, Switzerland, United Kingdom
Contacts
Public ContactProject & Regulatory Dept
European Organization for Research and Treatment of Cancer (EORTC)
Outcome results
None listed